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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
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envista hydrophobic intraocular lens Bausch & Lomb, Inc. P910056S019 11/19/2015
medtronic dbs therapy for parkinson's disease MEDTRONIC Inc. P960009S229 11/17/2015
valiant thoracic stent graft with the captivia delivery system Medtronic Vascular P100040S021 10/30/2015
coaptite injectable implant MERZ NORTH AMERICA, INC P040047S038 10/28/2015
radiesse injectable implant for sub-dermal implantation for restoration and or correction for the signs of facial fat lo MERZ NORTH AMERICA, INC P050037S056 10/28/2015
radiesse, radiesse (+), radiesse with lidocaine injectable implant MERZ NORTH AMERICA, INC P050052S062 10/28/2015
parascript (r) accudetect (r) PARASCRIPT, LLC P120004S001 10/16/2015
animas vibe system ANIMAS CORP. P130007S005 09/24/2015
evera mri xt dr, xt vr, s dr, s vr surescan icd's MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT P980016S536 09/11/2015
sprint quattro secure s mri surescan and sprint quattro secure mri surescan MEDTRONIC Inc. P920015S151 09/11/2015

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